30 Jul
|
Sunchem Industrial
|
Ahmedabad
30 Jul
Sunchem Industrial
Ahmedabad
Opening for Position RA Executive with experience of 1 Year to 2 years. Freshers will also be considered.
Qualification: B.Pharm / M.Pharm.
Key Responsibilities & Technical Requirements:
Preparation, compilation, review, and maintenance of regulatory dossiers for international markets.
Exposure to regulatory submissions for ASEAN, LATAM, and African countries will be preferred.
Working knowledge of regulatory documents such as:
CDP (Common Dossier Package)
RMP (Risk Management Plan)
AMV and other country-specific regulatory requirements
Understanding of country-specific registration guidelines, authority requirements, submission formats, regulatory checklists, and timelines.
Preparation and review of CTD/ACTD dossiers and related regulatory documentation.
Coordination with overseas clients, regulatory authorities, and manufacturing partners.
Management of international product registrations and lifecycle maintenance activities.
Identification of current business opportunities and support for business development initiatives.
Follow-up on quotations, agreements, registrations, commercial discussions, and client communications.
Maintenance and strengthening of client relationships through effective coordination and communication.
Pay: ₹18,000.00 - ₹30,000.00 per month
Perks:
Provident Fund
Work Location: In person
📌 Regulatory Affairs Executive Ahmedabad
🏢 Sunchem Industrial
📍 Ahmedabad